Received Mar 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | LA |
after giving the first dose, the patient experienced paralysis on the left side of her body (the vaccine was administered in the left arm) and had to go to the hospital.; This spontaneous report was received from a physician (gynecologist) via company representative and refers to a 40-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in December 2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), 1 dosage form administered in the left arm for prophylaxis (strength, dosage, lot # and expiration date and route of administration were not reported). On an unknown date, after the first dose, the patient experienced paralysis on the left side of her body (Hemiplegia) and had to go to the hospital. Therefore, at the time for the patient's second dose (at 2 months), the physician did not administer it because at that point she found out about the event. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided by the reporter (Nevertheless, at the hospital where patient was treated, she was told that it was caused by the vaccine). Upon internal review, the event was determined to be medically significant.